CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
BRIEFING INFORMATION
October 15, 1999
BLA #97-200
Medical Officer's Review
1.0 The EPILOG Trial -- Review of the EPILOG Study Report
2.0 Risk Status Assessment in the EPILOG Trial--Response to FDA Information Request
3.0 Review of the Independent Angiogram Re-Review Study Report
4.0 Review of the Aniographic Substudy of the EPILOG Trial
5.0 Clinical Review of the Readministration Study
BLA #93-1051 & 93-1057